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Registration Dossier
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EC number: 249-125-4 | CAS number: 28654-73-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (incomplete documentation, 20 h occlusive treatment, 2 animals, 72 h scoring not performed)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (occlusive treatment, 20h treatment duration, 72 h scoring not performed, 2 animals)
- Principles of method if other than guideline:
- BASF-test:
The test substance was applied to a 2.5 x 2.5 cm application site of white Vienna rabbits for 20 h under occlusive conditions. Additionally, the substance was applied for 1, 5 and 15 minutes. Animals were observed for 8 days and skin changes were observed on working days. Findings were recorded after 24, 48 hours, 5, 7 and 8 days after administration. Findings were graded as described in OECD test guideline 404. - GLP compliance:
- no
Test material
- Reference substance name:
- [N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper
- EC Number:
- 249-125-4
- EC Name:
- [N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper
- Cas Number:
- 28654-73-1
- Molecular formula:
- C47 H49 Cu N11
- IUPAC Name:
- Copper,[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyanine-C,C,C-trimethanaminato(2-)-κN29,κN30,κN31,κN32]-
- Details on test material:
- Please refer to confidential details on test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 3.75 kg (male) and 3.41 kg (female)
ENVIRONMENTAL CONDITIONS: not reported
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- other: untreated skin of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Concentration: 80% (in water) - Duration of treatment / exposure:
- 20 h
- Observation period:
- 7 days
- Number of animals:
- 2 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing: with water (possibly containing mild detergent)
- Time after start of exposure: 20 h
SCORING SYSTEM: as described in OECD guideline 404 (the BASF-code from the raw data was converted into the Draize scheme.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 - 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 - 48 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (2 animals)
- Time point:
- other: all timepoints
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Other effects:
- Substance residues (light-blue) were noted in both animals at 24 h and 48 h after exposure and in animal 2 until day 6.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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